Application for Ethical Clearance for a Research Project Involving Animal Participants

ITT Dublin RE_4 Form

To be completed by staff proposing to submit an application to conduct research involving animals. The signed original and an electronic copy of the completed form should be returned to the Secretary of the Research Ethics Committee.

Note: animal studies can only be conducted where the Institute has alicence to do so and has the approved animal facilities.

In Ireland, scientific research and experimental activity on live animals may only be performed where no alternative procedure is available and under licence from the Minister for Health and Children under the Cruelty to Animals Act, 1876 as amended by the European Communities (Amendment to Cruelty to Animals Act, 1876) Regulations, 1994.

Application forms for a licence to perform procedures on live animals may be obtained from: The Public Health Division, Department of Health, Hawkins House, Dublin 2. Telephone: 714711 Ext: 2538

Research must not commence until written approval has been received from the Research Ethics Committee.Guidelines to applicants submitting applications for ethical clearance are given in the document entitled “Process and Procedures for Seeking Ethics Clearance for Research Projects” and associated Appendix Document.

Please check that all supplementary information is attached to your application (in both hard and soft copy).

ATTACHED / NOT APPLICABLE
Evidence of external approvals related to the research
Ethical Approval from Other Committees Form
Bibliography
Monitoring checklist pro forma
Bibliography
Other(e.g. EPA application, Animal License application)

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SECTION 1:APPLICANT DETAILS

1.1General Information

PROJECT TITLE
THIS PROJECT IS: / Staff Research Project / Staff Research Project leading to academic award in another HEI
(tick as many as apply) / Contract Research Project / Clinical Trial
Funded Research / Consultancy Project
Student Research Project / Masters / Taught postgraduate
PhD / Undergraduate
Other
- Please Describe:
Project Start Date: / Project End Date:

1.2Investigator Contact Details

PRINCIPAL INVESTIGATOR(S):

TITLE / SURNAME / FIRST NAME / POSITION & ROLE IN RESEARCH / PHONE / FAX / EMAIL

OTHER INVESTIGATORS:

Including Collaborators and Off-Campus Supervisors

TITLE / SURNAME / FIRST NAME / POSITION & ROLE IN RESEARCH / PHONE / FAX / EMAIL
DEPARTMENT
SCHOOL
RESEARCH CENTRE

WILL THE RESEARCH BE UNDERTAKEN ON-SITE AT THE INSTITUTE OF TECHNOLOGY TALLAGHT?

YES / NO / (If NO, give details of off-campus location.)

IS THIS PROTOCOL BEING SUBMITTED TO ANOTHER ETHICS COMMITTEE, OR HAS IT BEEN PREVIOUSLY SUBMITTED TO AN ETHICS COMMITTEE?)

YES / NO / (If YES, please complete the Ethical Approval from Other Committees Form and provide letter of approval, detail on decision received etc.)

SECTION 2:DETAILS OF RESEARCH STUDY

In this section you are required to provide a brief outline of the project, aims, methods, duration, funding, profile of animals and proposed interaction with them. This description must be in everyday language that is free from jargon. Additional pages may be added where necessary.

2.1PROJECT OUTLINE - LAY DESCRIPTION

Please explain any technical terms or discipline-specific phrases. Provide a brief outline of the project, including what participants will be required to do. This description must be in everyday language which is free from jargon. Please explain any technical terms or discipline-specific phrases. (No more than 300 words).

2.2AIMS OF AND JUSTIFICATION FOR THE RESEARCH

State the aims and significance of the project (approx. 400 words). Also please provide a brief description of current research, a justification as to why this research should proceed and an explanation of any expected benefits to the community. NB – all references cited should be listed in an attached bibliography.

2.5PLEASE EXPLAIN WHEN, HOW, WHERE, AND TO WHOM RESULTS WILL BE DISSEMINATED?

2.6OTHER APPROVALS REQUIREDHas permission to gain access to another location, organisation etc. been obtained?

YES / NO / NOT APPLICABLE

(If YES, please specify from whom and attach a copy of approval letter. If NO, please explain when this will be obtained.)

2.7HAS A SIMILAR PROPOSAL BEEN PREVIOUSLY APPROVED BY THE RESEARCH ETHICS COMMITTEE?

YES / NO

(If YES, please state both the REC Application Number and Project Title)

SECTION 3:GENERAL INFORMATION ON ANIMAL PARTICIPANTS

3.1DETAILS OF ANIMALS REQUIRED

SPECIES
(AND COMMON NAME) / STRAIN /
AGE
/ TOTAL NUMBER PER PROJECT / SOURCE

3.2POTENTIAL IMPACT ON THE ANIMALS

Tick the correct classification and explain the reason for this classification, detailing all the procedures to be performed under anaesthetic with recovery, terminal or without anaesthetic, and how many of them each animal may experience.

MINOR
MODERATE
SUBSTANTIAL

Provide details to support this classification:

3.3PLEASE DETAIL THE IRISH LICENCE NUMBER THAT THIS WORK IS BEING EXAMINED UNDER (if available)

Note: animal studies can only be conducted where the Institute has a current licence to do so.

Licence Number:
EXPIRY DATE

3.4DOES THE PROPOSED RESEARCH REFER TO CONTINUING WORK?

YES / NO / (If YES, please provide details of previous work and indicate the additional information due to emerge from the continuing work)

3.5PLEASE CATEGORISE THE OBJECTIVE OF WORK:

Research
Teaching
Diagnostic/Forensic
Drug Testing/Manufacture
Other (please specify)

3.6IS THE USE OF LC50/LD50 INVOLVED?

YES / NO / (If YES, please give details and indicate why these tests are considered necessary.)

3.7IS THE DRAIZE EYE IRRITANCY TEST INVOLVED?

YES / NO / (If YES, give full details and indicate why this test is considered necessary.)

3.8DESCRIBE THE ANAESTHETIC AND ANALGESIC PROTOCOL INVOLVED IN THE PROPOSED RESEARCH:

3.9WILL ALL STAFF INVOLVED DIRECTLY IN THE ANIMAL MANIPULATIONS RECEIVE APPROPRIATE VACCINATIONS (IF NOT ALREADY VACCINATED)?

YES / NO / (If YES, please name the vaccines. If NO, please explain why.)

3.10ARE THERE PRECAUTIONS BEING EMPLOYED TO REDUCE ALLERGY TO LABORATORY ANIMALS (ALA) IN STAFF PERFORMING MANIPULATIONS?

YES / NO / (If YES, please list these preceuations. If NO, please explain why.)

SECTION 4:JUSTIFICATION FOR THE USE OF ANIMAL PARTICIPANTS

The ITT Dublin Research Ethics Committee (REC) must be satisfied that the use of animals is justified, based on whether the scientific or educational value of the work outweighs the potential impact on the animals being used. Overall, answers provided in this section should provide REB members, particularly external lay and welfare members, with a clear idea of why the experiments are necessary and what will happen to animals. All information provided in this section must be in language that can be understood by an interested, intelligent person without a scientific background. Do not use scientific jargon and avoid using abbreviations.

4.1HAVE ANY OF THE ANIMALS BEEN THE SUBJECT OF A PREVIOUS SCIENTIFIC OR TEACHING ACTIVITY?

YES / NO / If YES, provide details of what was done to them previously and justify their use in this project.

4.2ARE ALTERNATIVES THAT REPLACE, REDUCE OR REFINE THE USE OF ANIMALS BEING UTILIZED IN THIS PROJECT?

The aim of the REB is to ensure the ethical use and the humane care of animals used for scientific purposes. To this end, there is a need in scientific and teaching activities to consider methods that replace, reduce and refine the use of animals.

YES / NO / If YES, please describe what alternatives are being used.
If NO, please describe what alternatives were considered and explain
why they are unsuitable for this project.

4.3JUSTIFY THE NUMBER OF ANIMALS REQUESTED IN TERMS OF STATISTICAL CONSIDERATIONS AND/OR OTHER CONSIDERATIONS IN THE EXPERIMENTAL DESIGN

In accordance with the aim of the REB, there is a need in scientific and teaching activities to consider the reduction in the number of animals used. Note that in some cases however, it may be better to use more animals in order to minimise the impact on individual animals.

(Present the numbers in table form based on treatment group, where appropriate)

4.4TOREDUCE ANIMAL USE, WOULD THE ANIMALS OR THEIR TISSUES, AT THE CONCLUSION OF YOUR EXPERIMENTS, BE SUITABLE FOR USE IN ANOTHER PROJECT?

YES / NO / If NO, briefly describe why.

4.5JUSTIFY YOUR CHOICE OF ANIMAL (SPECIES/STRAIN)

Please provide references to justify your choice. NB – all references cited should be listed in an attached bibliography.

4.6DOES THE PROJECT INVOLVE THE USE OR PRODUCTION OF GENETICALLY MODIFIED ANIMALS, E.G. TRANSGENIC, KNOCKOUT?

In accordance withthe aim of the REB,, there is a need in scientific and teaching activities to consider the refinement of techniques used to reduce the impact on animals (Note that the use of such animals is also governed by the GMO (Contained Use) Regulations, 2001, S.I. No. 73 of 2001).

YES / NO / If YES, briefly describe the function/s of the gene/s that have been/will be modified and why their modification is relevant to the project.

IF YOU ANSWERED YES TO 4.6, PLEASE ANSWER QUESTIONS 4.7 AND 4.8:

4.7DESCRIBE HOW AND WHEN, TISSUE USED FOR GENOTYPING THE ANIMALS WILL BE COLLECTED.

4.8IS THE HEALTH, WELFARE, BREEDING OR LIFESPAN OF THESE ANIMALS LIKELY TO BE AFFECTED BY THE MODIFICATION?

YES / NO / UNKNOWN / If YES, provide a brief explanation
If UNKNOWN, provide a brief explanation

4.9FROM WHERE WILL THE ANIMALS BE OBTAINED?

4.10PLEASE PROVIDE EVIDENCE OF EPA REGISTRATION

4.11WILL ANIMALS NEED TO BE TRANSPORTED FROM THE SOURCE LOCATION TO THE LOCATION WHERE THEY WILL BE HELD FOR THIS PROJECT?

YES / NO / If YES, provide details of transportation and acclimatisation procedures.

4.12WHERE WILL ANIMALS BE HOUSED, AND WHAT TYPE OF HOUSING WILL BE USED?

Include details of methods used to ensure that housing meets the specific requirements of the animals being held. Describe any special housing requirements.

SECTION 5:MONITORING

5.1WHO WILL MONITOR THE ANIMALS? HOW OFTEN?

5.2WILL MONITORING CHECKLISTS BE USED?

YES / NO / If YES, please attach the checklist pro forma to this application.
If NO, explain how your observations will be recorded

SECTION 6:STORAGE AND DISPOSAL

This section should explain how any impact on the animals’ welfare will be assessed and managed.

Generally, investigators are responsible for keeping records of the care and use of animals once they have been allocated to an approved project. All personnel identified in this and the following section of the proposal must be aware of the criteria to be monitored and how records are to be kept. All records of observations made must be readily accessible to all nominated personnel and be made available to the REB if requested.

6.1ONCE ISSUED TO THE PROJECT, HOW LONG WILL INDIVIDUAL ANIMALS BE KEPT?

6.2WHAT WILL HAPPEN TO THE ANIMALS AT THE COMPLETION OF THE PROJECT?

6.3IF THE ANIMALS ARE TO BE KILLED, HOW WILL THIS BE DONE AND BY WHOM? (agent, dose rate, method and route of administration and experience of person carrying out the procedure)

6.4WHAT WILL BE THE METHOD OF DISPOSAL OF DEAD ANIMALS?

SECTION 7:QUALIFICATIONS, EXPEREINCE & SKILLS OF PROPOSED RESEARCHERS

List the academic qualifications and outline the experience and skills relevant to this project that the researchers and any supporting staff (either at ITT Dublin or an off-campus HEI) have in carrying out the research and in dealing with any emergencies, unexpected outcomes, or contingencies that may arise.

–In addition, evidence should be shown of training course completion (copy of certificate) or it should be agreed that such a course will be undertaken within the next six months.

No more than 200 words.

SECTION 8: DECLARATION BY INVESTIGATORS & APPROVAL SIGNATURES

I CONFIRM THAT THE REQUIRED ANIMALS CAN BE OBTAINED FROM AND/OR HOUSED IN THE ANIMAL FACILITY:

ANIMAL FACILITY MANAGER’S NAME:
ANIMAL FACILITY MANAGER’S SIGNATURE:
DATE:

I CONFIRM THAT THE ANIMAL ETHICS RESEARCH COMMITTEE HAS REVIEWED THIS PROPOSAL:

CHAIRPERSON’S NAME:
CHAIRPERSON’S SIGNATURE:
DATE:

PRINCIPAL INVESTIGATOR DECLARATION

The information contained herein is, to the best of my knowledge and belief, accurate. I have read and agree to comply with the Institute’s Code of Conduct for Researchers and Process and Procedures for Seeking Ethics Clearance for Research Projects. I have attempted to identify all risks related to the proposed research that may arise in conducting this research and acknowledge my obligations to and the rights of the participants. I am not aware of any other ethical issue not addressed within this form.

I and my co-investigators have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise.

I/We agree to abide by the decision of the Research Ethics Committee.

Name of Principal Investigator(s): ______

BLOCK CAPITALS

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Signature(s):

Principal Investigator(s):______

______

Date:______

P.T.O.

HEAD OF SCHOOL/DEPARTMENT APPROVAL

The Head of School/Department must countersign and date the application below:

I approve this study to be carried out under the auspices of my School/Department:

Name of Head of School/Department: ______

BLOCK CAPITALS

Signature: ______

Date: ______

WHERE THE APPLICANT IS REGISTERED FOR AN ACADEMIC AWARD AT ANOTHER HIGHER EDUCATION INSTITUTION THE SIGNATURE OF APPROVAL OF THE OFF-CAMPUS SUPERVISOR SHOULD BE OBTAINED:

I approve this study to be carried out:

Supervisor Name:______

BLOCK CAPITALS

Signature: ______

Date: ______

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